CuffGuard
The FDA filing identifies CuffGuard references CG-MU_ID and CG-MU_DR as an endotracheal tube cuff pressure controller. It is intended to continuously monitor and maintain user-defined cuff…
The FDA filing identifies CuffGuard references CG-MU_ID and CG-MU_DR as an endotracheal tube cuff pressure controller.
It is intended to continuously monitor and maintain user-defined cuff pressure for adults and children on mechanical ventilation with a cuffed endotracheal tube.
Listed Item
CuffGuard complete kit (Main Unit, User manual, 1 tube, clamp for tube and bar, power supply, angle edge)
Pressure Control
The filing describes a pressure sensor and software that monitor and automatically adjust cuff pressure.
Its stated settings include the ICU, operating room and intra-hospital transport.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Quasar Electronics Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| TDG Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Medtronic (Shanghai) Medical Technology Co., Ltd. | Min Hang District | Shanghai | Specification developer | 4 |
| Shanghai Longmann Tech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | Idmed Corp., United States |
|---|---|
| FDA product code | BSK |
| Device type | Cuff, Tracheal Tube, Inflatable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5750 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K243562 |
| Record published | 2025-12-19 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PWR5-U_UK | In distribution | ||
| PWR5-U_TI | In distribution | ||
| PWR5-U_TI | In distribution | ||
| PWR5-U_UK | In distribution | ||
| CG-TUB1 | 10 | In distribution | |
| PWR5-U_EU | In distribution | ||
| PWR5-U_US | In distribution | ||
| CG-MU_ID | In distribution | ||
| CG-MU_DR | In distribution | ||
| PWR5-U_EU | In distribution | ||
| CG-KIT_ID | In distribution | ||
| PWR5-U_US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cuff, Tracheal Tube, Inflatable | VBM Medizintechnik Gmbh | 6 |
| Rusch | Teleflex Medical LLC | 5 |
| Cuff, Tracheal Tube, Inflatable | Nuvasive, Inc. | 4 |
| Tracoe® technic | Tracoe Medical Gmbh | 4 |
| Medis | Tianjin Medis Medical Device Co., Ltd. | 3 |
| AincA® | Anesthesia Associates, Inc. | 2 |
| Puritan Bennett | Covidien LP | 2 |
| CuffTrek | Shanghai Longmann Tech Co., Ltd. | 2 |
| Posey | Posey Products, LLC | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Cuffix | Biovo Technologies, Ltd. | 2 |
| Ambu A/S | VBM Medizintechnik Gmbh | 2 |
Showing 12 of 29. All products under Cuff, Tracheal Tube, Inflatable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243562 | 2025-08-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.